BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000

    K Number: K030099 · Decision Jun 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    336
    Applicant Total
    503
    Review Days
    158

    Basic Information

    Device Name
    BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
    K Number
    K030099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BAXTER HEALTHCARE CORP.
    Date Received
    January 10, 2003
    Decision Date
    June 17, 2003
    Product Code
    KDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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